In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions.

Participants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions

Areas Covered in the Session:

Which regulatory bodies are responsible for medical device registration in each country?

Are medical devices required to be registered before they can be sold?

What are the different regulatory classifications for medical devices?

What are the different application categories for medical device registration?

What does the registration pathway look like for each regulatory classification?

What are the document requirements for notification for the various classes of medical devices?

What are other requirements that are necessary for approval in addition to the device application?

Is local testing (type testing/sample testing) required for registration?

When are clinical studies required for registration?

Is approval in the Country of Origin required for registration?

Who Will Benefit:

This seminar will provide an overview and in-depth snapshot of the medical device registration and approval process for Asia Pacific and with the corresponding regulatory authorities. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the medical device registration process, including:

Clinical Research Associates

Clinical Project Managers

Regulatory Affairs Professionals

Clinical Investigators and Clinical Research

Regulatory Affairs Management

Regulatory Affairs Specialists

Regulatory Project Leads/SME's

Auditors

Compliance Specialists

Clinical Affairs

Quality Assurance

Consultants

Distributors

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Please contact the event manager Marilyn below for the following:
- For Registrations Please call +1 929.900.1853
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

Agenda

Day 1 Schedule

Lecture 1: Medical Device Registration and Approval Process
Introductions and Background
China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia and overview of the pre and post-registration and approval process
What is the classification scheme for medical devices?
What are the registration procedures?
How are devices classified?
How do regulatory requirements differ for domestic vs. foreign manufacturers?
How long does it take to register devices?
New Registration Pathways for Manufacturers
Revised medical device registration and approval requirements in select countries
Quality management systems (QMS) are streamlined
QMS inspections with Marketing Authorization Holders and Manufacturers
Key Guidelines and Resources
Will our clinical studies and testing conducted outside the countries be accepted?

Lecture 2: Exercise and Recap of Day 1

Interactive Discussions
Review of Regulatory Documents

Day 2 Schedule

Lecture 1: Medical Device Registration and Approval Process
Medical Device Registration and Approval Process and Recap from Day 1
China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia and overview of the pre-registration and post-registration and approval process
Documentation required for review and approval
Registration and country codes and other requirements
In-Country Representative/Marketing Authorization Holders/Authorized Representatives
QMS and other requirements
Documentation and Additional Materials for Registration and Approval
Consultation sessions with Regulatory Authorities, how to maximize foreign clinical data, and how to expedite product registration
Trends and lessons learned with recent and current registrations
New medical device regulations and approval requirements are released on a regular basis sometimes and companies must keep track and current
Responding to inquiries and questions from the Regulatory Authorities/Agencies
Regulatory inspection process

Lecture 2: Exercise and Recap of Day 2

Interactive Discussions
Review of Regulatory Documents

Lecture 3: Debrief/Adjourn

Recap of topics and key discussion points and take away message
FAQs and latest trends

Speaker Details

David R. Dills

Global Regulatory Affairs & Compliance Consultant

David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company's commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.